Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the full-text guideline document.
The grades of recommendations (A-D) and levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.
Presentation, Screening and Risk Factors
Risk Factors
Smoking and Tobacco Use
B - The population of Scotland should be discouraged from smoking or chewing tobacco.
D - Healthcare professionals should put people in contact with the appropriate smoking cessation services.
C - Patients with precancerous oral lesions who use tobacco should be advised to give up.
Alcohol Consumption
B - The population of Scotland should be encouraged to limit their alcohol consumption, in line with government recommended guidelines.
D - Healthcare professionals should put people in contact with the appropriate alcohol counselling service.
Dietary Factors
C - The population of Scotland should be encouraged to increase their intake of fruit and vegetables (specifically tomatoes), olive oil and fish oils.
C - The population of Scotland should be encouraged to reduce their intake of red meat, fried food and fat.
Public Awareness
B - Leaflets about signs, symptoms and risks of head and neck cancer should be available in primary care.
Referral and Diagnosis
Referral
D - Rapid access or "one stop" clinics should be available for patients who fulfil appropriate referral criteria.
Diagnosis and Staging
Investigating Neck Lumps
D - Fine needle aspiration cytology should be used in the investigation of head and neck masses.
Endoscopy
D - All patients with head and neck cancer should have direct pharyngolaryngoscopy and chest X-ray with symptom-directed endoscopy where indicated.
Imaging the Primary Tumour
D - Computed tomography (CT) or magnetic resonance imaging (MRI) of the primary tumour site should be performed to help define the tumour (T) stage of the tumour.
D - MRI should be used to stage oropharyngeal and oral tumours.
D - MRI should be used in assessing:
- Laryngeal cartilage invasion
- Tumour involvement of the skull base, orbit, cervical spine or neurovascular structures (most suprahyoid tumours)
Imaging Neck Nodes
D - CT or MRI from skull-base to sternoclavicular joints should be performed in all patients at the time of imaging the primary tumour to stage the neck for nodal metastatic disease.
B - Where the nodal staging on CT or MRI is equivocal, ultrasound-guided fine needle aspiration (USFNA) and/or fluorodeoxyglucose positron emission tomography (FDG-PET) increase the accuracy of nodal staging.
Imaging for Distant Metastases and Synchronous Tumours
D - All patients with head and neck cancer should undergo CT of the thorax.
Metastatic Cervical Lymph Nodes with Unknown Primary
C - In patients presenting with cervical lymph node metastases, where CT or MRI does not demonstrate an obvious primary tumour, FDG-PET should be performed as the next investigation of choice.
Restaging Patients with Suspected Recurrent Disease
C - In patients presenting with suspected recurrent head and neck cancer, where CT/MRI does not demonstrate a clear cut recurrence, FDG-PET should be performed as the next investigation of choice.
Histopathology Reporting
Recommended Essential Data Items
Primary Site
C - Histopathology reporting of specimens from the primary site of head and neck cancer should include:
- Tumour site
- Tumour grade
- Maximum tumour dimension
- Maximum depth of invasion
- Margin involvement by invasive and/or severe dysplasia
- Pattern of infiltration
- Perineural involvement
- D - Tumour type
Metastatic Disease
C - Histopathology reporting of specimens from areas of metastatic disease in patients with head and neck cancer should include:
- Number of involved nodes
- Level of involved nodes
- Extracapsular spread of tumour
Overview and Treatment of the Primary Tumour and Neck
C - Patients with head and neck cancer, especially those planned for resection of oral cancers or whose teeth are to be included in a radiotherapy field, should have the opportunity for a pre-treatment assessment by an appropriately experienced dental practitioner.
Management of Clinically Node Negative Neck
C - Patients with a clinically node negative (N0) neck, with more than 20% risk of occult nodal metastases, should be offered prophylactic treatment of the neck, either by appropriate selective or modified radical neck dissection or by external beam radiotherapy.
Management of Clinically Node Positive Neck
D - Patients with clinically N1 disease should be treated by appropriate neck dissection or radical radiotherapy (with or without chemotherapy).
D - In patients with clinically N1 disease and a complete clinical response to radiotherapy, observation rather than further surgical management is recommended.
D - Following neck dissection for clinically N1 disease, adjuvant postoperative radiotherapy must be considered for those patients who are at high risk of locoregional recurrence.
D - Patients with clinical N2 or N3 disease should be treated either by:
- Comprehensive neck dissection followed by external beam radiotherapy, or
- Radical radiotherapy followed by comprehensive neck dissection
D - In patients where the primary tumour is small and the nodal disease is resectable, neck dissection may be performed before treating both the primary tumour and the neck with radiotherapy (with or without chemotherapy).
Treatment: Radiotherapy as the Major Treatment Modality
Modified Fractionation
Modified Fractionation and Chemotherapy
A - Where radiotherapy is the primary treatment modality, moderately accelerated schedules (six fractions/week) or hyperfractionated schedules with increased total dose should be considered for patients with head and neck cancer (except T1-3 glottic or supraglottic) who are unable to receive concurrent chemotherapy or cetuximab.
Interruptions to Planned Radiotherapy Treatment Schedules
C - Interrupting and prolonging a course of radical radiotherapy should be avoided.
Brachytherapy
D - Patients with small accessible (T1/2) tumours of the oral cavity and oropharynx may be treated by interstitial brachytherapy to a dose of 65-70Gy at a dose rate of less than 0.55Gy/hour.
Prevention and Treatment of Radiation Side Effects
Prevention and Treatment of Radiation-Induced Mucositis
A - Patients with oral cavity, laryngeal, oropharyngeal or hypopharyngeal tumours who are being treated with radiotherapy should be offered benzydamine oral rinse before, during, and up to three weeks after completion of radiotherapy.
Prevention and Treatment of Radiation-Induced Xerostomia
A - Pilocarpine (5 to 10 mg three times per day) may be offered to improve radiation-induced xerostomia following radiotherapy to patients with evidence of some intact salivary function, providing there are no medical contraindications to its use.
Treatment: Surgery as the Major Treatment Modality
Resection
D - If an inadequate initial excision biopsy has been performed or if the tumour has been excised with positive excision margins, re-resection should be considered.
Adjuvant Radiotherapy Following Surgery
C - Postoperative radiotherapy should be considered following surgical resection of oral cavity, oropharyngeal, laryngeal and hypopharyngeal cancers for patients with the following adverse risk features:
- Oral cavity primary tumour
- Advanced T stage
- Close or positive surgical margins
- Perineural invasion
- Lymphovascular invasion
- Any positive lymph nodes, but especially if more than one node is positive
- Positive nodes at level IV (lower internal jugular nodes) or V (posterior triangle nodes)
- Any node 3 cm or greater
- Extracapsular lymph node spread
A - Postoperative radiotherapy should be conventionally fractionated:
- 54-60Gy in 27-30 fractions over 5.5-6 weeks to the primary site and nodes at risk
- 66Gy in 33 fractions over 6.5 weeks to areas of very high risk
B - Overall treatment time from surgery to completion of radiotherapy should be 10-11 weeks or less in the absence of postoperative medical or surgical complications.
A - In patients with extracapsular spread and/or positive surgical margins, who are medically fit, postoperative concurrent chemoradiotherapy with single agent cisplatin and conventionally fractionated radiotherapy should be considered.
Treatment: Chemotherapy in Combination with Surgery or Radiotherapy
Chemotherapy with Locoregional Therapy
A - In patients with locally advanced non-metastatic squamous carcinoma of the oral cavity, oropharynx, larynx and hypopharynx, who are medically fit for chemotherapy, (especially those aged 70 or under), concurrent chemoradiotherapy should be considered rather than radiotherapy alone if:
- Organ preservation is being pursued
- The primary tumour is unresectable
A - Single agent cisplatin is recommended as the chemotherapeutic agent of choice in concurrent chemoradiotherapy.
A - The routine use of neoadjuvant chemotherapy in oral cavity, oropharyngeal and laryngeal cancer is not recommended.
A - Neoadjuvant cisplatin/5-fluorouracil (5FU) followed by radical radiotherapy alone may be used in patients with locally advanced resectable hypopharyngeal cancers who have a complete response to chemotherapy.
A - The routine use of adjuvant chemotherapy following radiotherapy is not recommended.
A - The routine use of neoadjuvant or adjuvant chemotherapy in combination with surgery is not recommended.
A - Concurrent chemoradiotherapy should only be administered where there are appropriate facilities for monitoring toxicity, with rapid access to appropriate outpatient and inpatient support for the treatment of acute radiotherapy and chemotherapy toxicity.
Cetuximab in Addition to Radiotherapy
A - In patients undergoing radical radiotherapy for locally advanced head and neck cancer, who are medically unfit for concurrent chemoradiotherapy, concurrent administration of cetuximab with radiotherapy should be considered.
Treatment: Management of Locoregional Recurrence
Salvage Surgery after Previous Radiotherapy or Surgery
D - Salvage surgery should be considered in any patient with a resectable locoregional recurrence of oral cavity, oropharyngeal, laryngeal or hypopharyngeal cancer following previous radiotherapy or surgery.
Radiotherapy and Re-irradiation
D - Selected patients who have unresectable locally recurrent disease following previous radiotherapy may be considered for potentially curative re-irradiation.
D - Patients with small accessible recurrences in a previously irradiated region may be considered for interstitial brachytherapy in centres with appropriate facilities and expertise.
Treatment: Palliation of Incurable Disease
Palliative Chemotherapy
A - Patients of adequate performance status should be considered for palliative chemotherapy which may reduce tumour volume.
A - Single agent methotrexate, single agent cisplatin, or cisplatin/5FU combination should be considered for palliative chemotherapy in patients with head and neck cancer.
A - Excessive toxicity from intensive chemotherapeutic combination regimens should be avoided.
Palliative Radiotherapy
D - Radiotherapy may be considered for palliative treatment in patients with locally advanced incurable head and neck cancer.
Laryngeal Cancer
Early Laryngeal Cancer (Stage I and II)
Early Glottic Cancer
D - Patients with early glottic cancer may be treated either by external beam radiotherapy or conservation surgery.
B - When external beam radiotherapy is used as the primary treatment modality in patients with early glottic cancer, hypofractionated regimens with fraction size >2Gy (e.g., 53-55Gy in 20 fractions over 28 days or 50-52Gy in 16 fractions over 22 days) without concurrent chemotherapy should be used.
D - Surgery for patients with early glottic cancer may be either endoscopic laser excision or partial laryngectomy.
D - Prophylactic treatment of the neck nodes is not required for patients with early glottic cancer.
Early Supraglottic Cancer
D - Patients with early supraglottic cancer may be treated by either external beam radiotherapy or conservation surgery.
D - Radiotherapy for patients with early supraglottic cancer should include prophylactic bilateral treatment of levels II-III lymph nodes (upper and middle internal jugular nodes) in the neck.
D - Endoscopic laser excision or supraglottic laryngectomy with selective neck dissection to include levels II-III nodes should be considered for patients with early supraglottic cancer.
D - Neck dissection should be bilateral if the tumour is not well lateralised.
Locally Advanced Laryngeal Cancer (Stage III and IV)
A - Patients with locally advanced resectable laryngeal cancer should be treated by:
- Total laryngectomy with or without postoperative radiotherapy
- An initial organ preservation strategy reserving surgery for salvage
A - Treatment for organ preservation or non-resectable disease should be concurrent chemoradiation with single agent cisplatin.
A - In patients medically unsuitable for chemotherapy, concurrent administration of cetuximab with radiotherapy should be considered.
A - Radiotherapy should only be used as a single modality when comorbidity precludes the use of concurrent chemotherapy, concurrent cetuximab or surgery.
A - Where radiotherapy is being used as a single modality without concurrent chemotherapy or cetuximab, a modified fractionation schedule should be considered.
D - In patients with clinically N0 disease, nodal levels II-IV should be treated prophylactically by:
- Surgery (selective neck dissection)
- External beam radiotherapy
If the tumour is not well lateralised both sides of the neck should be treated.
D - Patients with a clinically node positive neck should be treated by:
- Modified radical neck dissection, with postoperative chemoradiotherapy or radiotherapy when indicated
- Chemoradiotherapy followed by neck dissection when there is clinical evidence of residual disease following completion of therapy (N1 disease)
- Chemoradiotherapy followed by planned neck dissection (N2 and N3 disease)
The target volume should include neck nodal levels II-IV.
D - Postoperative radiotherapy should be considered for patients with clinical and pathological features that indicate a high risk of recurrence.
A - Administration of cisplatin chemotherapy concurrently with postoperative radiotherapy should be considered, particularly in patients with extracapsular spread and/or positive surgical margins.
Hypopharyngeal Cancer
Early Hypopharyngeal Cancer (Stage I and II)
D - Patients with early hypopharyngeal cancer may be treated by:
- Radical external beam radiotherapy with concomitant cisplatin chemotherapy and prophylactic irradiation of neck nodes (levels II-IV bilaterally)
- Conservative surgery and bilateral selective neck dissection (levels II-IV, where local expertise is available)
- Radiotherapy alone in those patients who are not suitable for either concurrent chemoradiation or surgery due to comorbidity.
D - Postoperative radiotherapy should be considered for patients with clinical and pathological features that indicate a high risk of recurrence.
A - Administration of cisplatin chemotherapy concurrently with postoperative radiotherapy should be considered, particularly in patients with extracapsular spread and/or positive surgical margins.
Locally Advanced Hypopharyngeal Cancer (Stage III and IV)
A - Patients with resectable locally advanced hypopharyngeal cancer may be treated by:
- Surgical resection
- An organ preservation approach
A - For patients with resectable locally advanced hypopharyngeal cancer who wish to pursue an organ preservation strategy, external beam radiotherapy with concurrent cisplatin chemotherapy should be considered.
A - Neoadjuvant cisplatin/5FU followed by radical radiotherapy alone may be used in patients who have a complete response to chemotherapy.
D - Patients with resectable locally advanced disease should not be treated by radiotherapy alone unless comorbidity precludes both surgery and concurrent chemotherapy.
A - Patients with unresectable disease should be treated by external beam radiotherapy with concurrent cisplatin chemotherapy.
A - In patients medically unsuitable for chemotherapy, concurrent administration of cetuximab with radiotherapy should be considered.
A - Where radiotherapy is being used as a single modality without concurrent chemotherapy or cetuximab, a modified fractionation schedule should be considered.
D - Patients with a clinically N0 neck should undergo prophylactic treatment of the neck, either by selective neck dissection or radiotherapy, including nodal levels II-IV bilaterally.
D - Patients with a clinically node positive neck should be treated by:
- Modified radical neck dissection, with postoperative chemoradiotherapy or radiotherapy when indicated
- Chemoradiotherapy followed by neck dissection when there is clinical evidence of residual disease following completion of therapy (N1 disease)
- Chemoradiotherapy followed by planned neck dissection (N2 and N3 disease)
The target volume should include neck nodal levels II-IV.
D - In patients with a small primary tumour, locally advanced nodal disease may be resected prior to treating the primary with definitive radiotherapy (with or without chemotherapy) and the neck with adjuvant radiotherapy (with or without chemotherapy).
D - Postoperative radiotherapy should be considered for patients with clinical and pathological features that indicate a high risk of recurrence.
A - Administration of cisplatin chemotherapy concurrently with postoperative radiotherapy should be considered, particularly in patients with extracapsular spread and/or positive surgical margins.
Oropharyngeal Cancer
Early Oropharyngeal Cancer (Stage I and II)
D - Patients with early oropharyngeal cancer may be treated by:
- Primary resection, with reconstruction as appropriate, and neck dissection (selective neck dissection encompassing nodal levels II-IV, or II-V if base of tongue)
- External beam radiotherapy encompassing the primary tumour and neck nodes (levels II-IV, or levels II-V if base of tongue)
D - Patients with small accessible tumours may be treated by a combination of external beam radiotherapy and brachytherapy in centres with appropriate expertise.
D - In patients with well-lateralised tumours prophylactic treatment of the ipsilateral neck only is required.
D - Bilateral treatment of the neck is recommended when the incidence of occult disease in the contralateral neck is high (tumour is encroaching on base of tongue or soft palate).
D - Postoperative radiotherapy should be considered for patients with clinical and pathological features that indicate a high risk of recurrence.
A - Administration of cisplatin chemotherapy concurrently with postoperative radiotherapy should be considered, particularly in patients with extracapsular spread and/or positive surgical margins.
Locally Advanced Oropharyngeal Cancer (Stage III and IV)
D - Patients with advanced oropharyngeal cancer may be treated by:
- Primary surgery (if a clear surgical margin can be obtained)
- An organ preservation approach
Primary Surgery
D - Patients treated by primary surgery who have a clinically node positive neck should have a modified radical neck dissection.
D - Postoperative chemoradiotherapy to the primary site and neck should be considered for patients treated by primary surgery who show high risk pathological features.
A - Administration of cisplatin chemotherapy concurrently with postoperative radiotherapy should be considered, particularly in patients with extracapsular spread and/or positive surgical margins.
Organ Preservation Therapy
A - Radiotherapy should be administered with concurrent cisplatin chemotherapy.
D - The primary tumour and neck node levels (II-V) should be treated bilaterally.
A - In patients medically unsuitable for chemotherapy, concurrent administration of cetuximab with radiotherapy should be considered.
A - Where radiotherapy is being used as a single modality without concurrent chemotherapy or cetuximab, a modified fractionation schedule should be considered.
- D - Patients with N1 disease should be treated with chemoradiotherapy followed by neck dissection where there is clinical evidence of residual disease following completion of therapy.
- D - Patients with N2 and N3 nodal disease should be treated with chemoradiotherapy followed by planned neck dissection.
D - In patients with a small primary tumour, locally advanced nodal disease may be resected prior to treating the primary with definitive chemoradiotherapy and the neck with adjuvant chemoradiotherapy.
Oral Cavity Cancer
Early Oral Cavity Cancer (Stage I and II)
D - Patients with early oral cavity cancer may be treated by:
- Surgical resection, where rim rather than segmental resection should be performed, where possible, in situations where removal of bone is required to achieve clear histological margins
- Brachytherapy in accessible, well demarcated lesions
D - Re-resection should be considered to achieve clear histological margins if the initial resection has positive surgical margins.
D - The clinically N0 neck (levels I-III [submental and submandibular nodes and upper and middle internal jugular nodes]) should be treated prophylactically either by external beam radiotherapy or selective neck dissection.
D - Postoperative radiotherapy should be considered for patients who have positive nodes after pathological assessment.
D - Postoperative radiotherapy should be considered for patients with clinical and pathological features that indicate a high risk of recurrence.
A - Administration of cisplatin chemotherapy concurrently with postoperative radiotherapy should be considered, particularly in patients with extracapsular spread and/or positive surgical margins.
Advanced Oral Cavity Cancer (Stage III and IV)
D - Patients with resectable disease who are fit for surgery should have surgical resection with reconstruction.
D - Patients with node positive disease should be treated by modified radical neck dissection.
D - Elective dissection of the contralateral neck should be considered if the primary tumour is locally advanced, arises from the midline, or if there are multiple ipsilateral nodes involved.
A - Radical external beam radiotherapy with concurrent cisplatin chemotherapy should be considered when:
- The tumour cannot be adequately resected
- The patient's general condition precludes surgery
- The patient does not wish to undergo surgical resection
D - Nodal levels I-IV should be irradiated bilaterally.
D - Patients with N1 disease who are receiving radiotherapy to the primary tumour should be treated with chemoradiotherapy where there is clinical evidence of residual disease following completion of therapy.
D - Patients with N2 and N3 nodal disease who are receiving radiotherapy to the primary tumour should be treated with chemoradiotherapy followed by planned neck dissection.
A - In patients medically unsuitable for chemotherapy, concurrent administration of cetuximab with radiotherapy should be considered.
A - Where radiotherapy is being used as a single modality without concurrent chemotherapy or cetuximab, a modified fractionation schedule should be considered.
D - Postoperative radiotherapy should be considered for patients with clinical and pathological features that indicate a high risk of recurrence.
A - Administration of cisplatin chemotherapy concurrently with postoperative radiotherapy should be considered, particularly in patients with extracapsular spread and/or positive surgical margins.
Follow Up, Rehabilitation and Patient Support
Follow Up
Frequency of Follow Up
D - Patients should be seen frequently and regularly within the first three years post-treatment.
Interventions
C - Patients should have access to PET scanning, if appropriate, when recurrence is suspected.
C - Patients' weight should be monitored at follow up.
C - Patients' complaints of pain should be investigated.
A - Pilocarpine (5-10 mg three times per day) may be offered to improve radiation-induced xerostomia in those patients with evidence of some intact salivary function, providing there are no medical contraindications to its use.
B - Routine use of chest X-rays or serum markers is not recommended.
A - During follow up, routine supplementation with beta carotene is not recommended.
Rehabilitation
Oral and Dental Rehabilitation
C - Patients receiving oral surgery or radiotherapy to the mouth (with or without adjuvant chemotherapy) should have post-treatment dental rehabilitation.
C - Patients should access lifelong dental follow up and dental rehabilitation.
C - Dental extractions in irradiated jaws should be carried out in hospital by a specialist practitioner.
C - Hyperbaric oxygen facilities should be available for selected patients.
Speech and Language Therapy
Dysphagia
C - Head and neck cancer patients with dysphagia should receive appropriate speech and language therapy to optimise residual swallow function and reduce aspiration risk.
C - All patients with oral, oropharyngeal, hypopharyngeal and laryngeal cancer should have access to instrumental investigation for dysphagia.
- Modified barium swallow (MBS) and fibre optic endoscopic evaluation of swallow (FEES) are both valid methods for assessing dysphagia
- The speech and language therapist (SLT) should consider which is the most appropriate for different patients in different settings
C - All patients undergoing chemoradiation should have access to a specialist SLT before, during and after treatment.
Communication
C - Where communication problems are likely to occur, patients should be seen by a specialist head and neck SLT soon after diagnosis and before treatment commences.
C - Patients undergoing laryngectomy should have specialist speech and language therapy to restore voice either by a tracheoesophageal voice prosthesis and/or oesophageal speech.
C - Patients with communication impairment should have access to a SLT.
Nutritional Support
C - After screening, at-risk patients should receive early intervention for nutritional support by an experienced dietitian.
C - The multidisciplinary team should include healthcare professionals skilled in gastrostomy placement.
Patient Support
Information Needs
B - Leaflets about risk factors, prevention and early detection of head and neck cancer should be available in primary care.
Definitions:
Levels of Evidence
1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias
1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++: High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2+: Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3: Non-analytic studies (e.g., case reports, case series)
4: Expert opinion
Grades of Recommendation
Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation.
A: At least one meta-analysis, systematic review of RCTs, or RCT rated as 1++ and directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D: Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
